Finished product reference · In the Hanpars portfolio
Betahistine Dihydrochloride
Tablet · Oral · 16 mg
- List code
- 8828
- Pharmacologic class
- Histamine analogue (H1 partial agonist / H3 antagonist); antivertigo agent
What it is and how it works
Betahistine is a structural analogue of histamine with weak H1-agonist and stronger H3-antagonist activity. It is thought to improve microcirculation in the inner ear and to facilitate vestibular compensation by increasing histamine turnover in the brainstem.
Indications
Vertigo, tinnitus and hearing loss associated with Ménière’s disease.
Dosage and administration (summary)
Oral: 24–48 mg daily in divided doses (e.g. 8–16 mg three times daily), preferably with food.
Contraindications
Phaeochromocytoma; hypersensitivity to betahistine.
Warnings and precautions
Use with caution in patients with a history of peptic ulcer, bronchial asthma or urticaria/rash. Mild gastrointestinal upset, headache and hypersensitivity reactions may occur. Antihistamines may theoretically reduce its effect.
Pregnancy
Avoid in pregnancy unless clearly necessary; data are insufficient.
Storage and supply
Store below 25 °C, protected from moisture.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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